Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021;26(1):4-20.
doi: 10.5863/1551-6776-26.1.4. Epub 2021 Jan 4.

Melatonin Use in Pediatrics: Evaluating the Discrepancy in Evidence Based on Country and Regulations Regarding Production

Michelle Skrzelowski, Amanda Brookhaus, Leticia A Shea, Daniel J Berlau
Review

Melatonin Use in Pediatrics: Evaluating the Discrepancy in Evidence Based on Country and Regulations Regarding Production

Michelle Skrzelowski et al. J Pediatr Pharmacol Ther. 2021.

Abstract

Melatonin manufacturers in the United States have begun producing melatonin products specifically targeted for use in the pediatric population. This paper aims to critically evaluate the evidence available regarding the use of melatonin in children based on where the clinical trials are performed and the regulations regarding the production of melatonin in that country. Melatonin is regulated differently around the world with the least amount of regulation placed on OTC supplements in the United States. The majority of studies evaluating melatonin use in the pediatric population are conducted with children who have comorbidities, such as autism spectrum disorder or attention-deficit/hyperactivity disorder. Evidence supporting the use of US formulations of melatonin in the otherwise healthy pediatric population is non-existent. Based on the lack of safety regulations in place in the United States and the lack of evidence regarding US melatonin products, they should be used sparingly in the otherwise healthy pediatric population, if they are used at all.

Keywords: child; maintenance disorders; melatonin; non-prescription; pediatrics; pharmaceutical regulation; sleep initiation.

PubMed Disclaimer

Conflict of interest statement

Disclosure. The authors declare no conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. US Department of Health and Human Services National Institutes of Health. Melatonin: what you need to know. Accessed February 26, 2020. nccih.nih.gov/health/melatonin.
    1. Buscemi N, Vandermeer B, Hooton N et al. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. Br Med J. 2006;332(7538):385–388. - PMC - PubMed
    1. Andrisano V, Bertucci C, Battaglia A, Cavrini V. Photostability of drugs: photodegradation of melatonin and its determination in commercial formulations. J Pharm Biomedical Anal. 2000;23(1):15–23. - PubMed
    1. Scheer FAJL, Wright KP, Kronauer RE, Czeisler CA. Plasticity of the intrinsic period of the human circadian timing system. PLoS One. 2007;2(8):e721. doi: 10.1371/journal.pone.0000721. doi. - DOI - PMC - PubMed
    1. Cavallo A, Ritschel WA. Pharmacokinetics of melatonin in human sexual maturation. J Clin Endocrinol Metab. 1996;81(5):1882–1886. - PubMed

LinkOut - more resources